BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REOCOR S

    MDR report key: 17786194 · Received September 20, 2023

    Report

    Report Number
    1028232-2023-04610
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 9, 2023
    Report Date
    September 25, 2023
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OVJ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE RECEIVED YOUR EVENT DESCRIPTION FOR THE DEVICE AND WOULD LIKE TO THANK YOU FOR SUPPORTING OUR POST-MARKET SURVEILLANCE. AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS, THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE ANALYSIS IS THEREFORE BASED ON THE AVAILABLE INFORMATION. AS ALREADY MENTIONED IN THE COMPLAINT DESCRIPTION, THE PATIENT CABLE USED IN THE PROCEDURE WAS REPLACED, AFTERWARDS THE EXTERNAL PACEMAKER WORKED AS EXPECTED. BASED ON THIS INFORMATION, IT HAS TO BE ASSUMED THAT THE ROOT CAUSE OF THE CLINICAL OBSERVATION IS TO BE FOUND IN THE PATIENT CABLE USED, OR AN INSUFFICIENT CONNECTION OF THE PATIENT CABLE. THE INFORMATION YOU PROVIDED HAS BEEN ENTERED INTO OUR QUALITY SYSTEM AS A COMPLAINT. THESE TYPES OF COMPLAINTS ARE USED TO EVALUATE SYSTEMS AND DEVICE PERFORMANCE THROUGHOUT OUR ORGANIZATION AND HELP TO MAINTAIN AND IMPROVE THE PERFORMANCE OF OUR DEVICES.

    Description of Event or Problem · 0

    THE DEVICE CANNOT PACE WHEN CONNECTING WITH THE TEMPORARY CABLE. THE SIGNAL WAS UNSTABLE AND LED TO PATIENT HAVING BRADYCARDIA, SLOW HEART RATE AND CARDIAC ARREST. A NEW CABLE WAS USED AND DEVICE FUNCTION RETURNED TO NORMAL. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997745 REOCOR S EXTERNAL PACEMAKER OVJ BIOTRONIK SE & CO. KG 365528

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization